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Lykiri

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Lykiri

Re: longfellow95 post# 196868

Sunday, 11/11/2018 7:00:57 PM

Sunday, November 11, 2018 7:00:57 PM

Post# of 704636
Longfellow95,

Thank you for the information about Accelerated assessment!
You are right!

Accelerated assessment (AA)
Procedure for applying for AA:
Step 1: Early presubmission dialogue (6-7 months prior MAA)
>mutual understanding that the data package is mature.


https://c.ymcdn.com/sites/www.celltherapysociety.org/resource/resmgr/2015EU_RegMtgPresentations/PlenarySeville1_2/Fri/15.09.25-1415-Celis.pdf
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